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Advances in Formulation and Technological Strategies for Montelukast Pulmonary Delivery
Carla Giordani Testa1,2, Millena de Sousa Afonso1, João Vitor Vicente-da-Silva1
1Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal Do Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil.
ACS Omega
|August 14, 2026
Summary
Developing inhalable montelukast offers improved asthma treatment by targeting lungs directly. Challenges remain in formulation and delivery, indicating a need for further research and development for this promising pulmonary drug therapy.
Area of Science:
- Pharmaceutical Sciences
- Respiratory Medicine
- Drug Delivery
Background:
- Conventional oral montelukast (leukotriene receptor antagonist) faces bioavailability issues due to first-pass metabolism and short half-life.
- Systemic adverse effects and variable therapeutic outcomes necessitate improved drug delivery methods for asthma management.
- Pulmonary drug delivery offers direct lung targeting, potentially bypassing metabolism and reducing systemic exposure.
Purpose of the Study:
- To review challenges and recent advances in formulating inhalable montelukast for pulmonary administration.
- To identify and analyze existing research on inhalable montelukast formulations and clinical studies.
- To highlight opportunities for developing effective inhaled montelukast therapies.
Main Methods:
- Literature search for inhalable montelukast formulations and clinical studies.
- Analysis of twenty identified articles focusing on dry powder inhalers (DPIs), nebulizers, and metered-dose inhalers (pMDIs).
- Evaluation of formulation strategies, particle engineering, inhalation devices, and reported outcomes.
Main Results:
- Sixteen articles focused on DPIs, with optimal mass median aerodynamic diameter (MMAD) of 1-5 μm for lung deposition.
- Formulation performance relies on burst release, sustained release, low permeability, and pulmonary retention.
- Limited clinical studies and patents indicate a translational gap in inhalable montelukast development.
Conclusions:
- Pulmonary delivery of montelukast presents significant potential for improved asthma treatment.
- Particle engineering and advanced formulation strategies are crucial for overcoming delivery challenges.
- Further research and development are needed to bridge the translational gap and commercialize inhalable montelukast therapies.
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